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Completed

NCT Number: NCT00331864

SUSTAIN - Study of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Ranibizumab is a humanised recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A. This study will assess the safety and efficacy of ranibizumab administered on an as-needed dosing regimen in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

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Key information

Conditions

Age Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis - 64 sites in 11 countries

Basel, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Patients who participated in this study included those who had completed participation in the study CRFB002A2301 (ANCHOR; NCT00061594), newly diagnosed patients, as well as previously diagnosed patients who had had recent disease progression.

Inclusion criteria

  • Male or female patients > 50 years of age
  • Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
  • The total area of CNV (including both classic and occult components) encompassed within the lesion must be >= 50% of the total lesion area
  • The total lesion area must be <= 12 disc areas
  • Patients who have a BCVA (best corrected visual acuity) score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like (Early Treatment of Diabetic Retinopathy Study) grading charts (approximately 20/40 to 20/320)

Exclusion criteria

  • Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
  • Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy or pegaptanib sodium in the study eye within 30 days preceding Day 1
  • Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

ranibizumab

Drug

Other names: rhuFab V2

Primary outcomes

  1. Percentage of Patients With Ocular Adverse Events (AEs) in the Study Eye

    Time frame: Baseline through end of study (12 month treatment period)

    Percentage of patients with ocular adverse events in the study eye over the one year (12 month) treatment period.

  2. Percentage of Patients With Targeted Grade 3 Adverse Events (AEs) in the Study Eye

    Time frame: Baseline through end of study (12 month treatment period)

    Grade 3 targeted AEs included:

    • 4+ ocular inflammation or 2-3+ ocular inflammation failing to decrease to ≤ 1+ within 30 days
    • ≥ 30 letter decrease in BCVA that developed within 14 days of ranibizumab injection
    • sustained (>15 minutes) loss of light perception due to elevated intraocular pressure (IOP) or a >20 mm Hg change in IOP persisting longer than 14 days
    • new retinal tear or detachment involving the macula
    • new vitreous hemorrhage >2+ severity not resolving within 14 days
    • new or increase of previous retinal hemorrhage >1 disc area in size and involving the fovea

Secondary outcomes

  1. Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 3

    Time frame: Baseline and Month 3

    BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.

    BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.

  2. Mean Change in Best Corrected Visual Acuity (BCVA) of the Study Eye From Baseline to Month 12

    Time frame: Baseline and Month 12

    BCVA was assessed using best correction determined from protocol refraction. BCVA measurements were taken in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at an initial testing distance of 4 meters.

    BCVA is measured by the number of letters a patient could correctly read on an eye chart; hence an increased score indicates improvement in acuity.

  3. Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 3

    Time frame: Baseline and Month 3

    Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).

  4. Mean Change in Central Retinal Thickness of the Study Eye From Baseline to Month 12

    Time frame: Baseline and Month 12

    Central retinal thickness was assessed using optical coherence tomography (OCT). OCT imaging was performed by trained personnel at each site using the Zeiss Stratus OCT™ 3 with version A6.1 (or more recent) software. Analysis of the OCT images was performed by the investigator. A negative number indicates improvement (reduced thickness).

  5. Time to the First Retreatment After Month 2

    Time frame: Month 2 to Month 11

    Time to first re-treatment is calculated as time difference in months starting from Month 2 until the month of first re-treatment.

    Criteria for re-treatment:

    • a >5 letter decrease in BCVA (determined using EDRS charts) based upon the highest visual acuity score from any prior scheduled study visit (Months 0, 1, 2 or 3)
    • a >100 µm increase in central retinal thickness (determined using OCT) from the thinnest measurement from any prior scheduled study visit (Months 0, 1, 2 or 3)

  6. Total Number of Treatments

    Time frame: Baseline (Month 0) to Month 11

    Total number of treatments administered during the entire treatment period (Month 0 to 11).

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Phase IIIb, Open-label, Multi-center 12 Month Study to Evaluate the Safety, Tolerability and Efficacy of Ranibizumab (0.3 mg and/or 0.5 mg) in Patients With Subfoveal Choroidal Neovasculariza-tion Secondary to Age-related Macular Degeneration

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
May 31, 2006
Registry last updated
Feb 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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